The University of Nebraska Medical Center and Nebraska Medicine have launched a new clinical research trial for adults who live with someone who tests positive for COVID-19. The trial will assess whether Molnupiravir, an oral antiviral, can prevent COVID-19. The trial will also assess the safety of the drug.
Clinical trials are research studies performed with human volunteers that aim to assess whether experimental treatments and vaccines are safe and effective for humans.
To date, there have been more than 5 million deaths worldwide from COVID-19, according to the World Health Organization.
Molnupiravir (also known as MK-4482 and EIDD-2801) is an investigational drug that can be swallowed and, in preclinical studies, has been shown to be able to prevent the growth of SARS-CoV-2, the virus that causes COVID-19. The trial is sponsored by Merck Sharp & Dohme Corp.
The primary objective of the randomized, double-blind, placebo-controlled phase 2 and 3 study called MOVe-AHEAD is to assess whether molnupiravir, compared to placebo, is safe and effective in preventing hospitalization or death in adults residing with someone who has COVID-19.
Study participants will be randomly assigned to receive either the study drug or a placebo every 12 hours for five days. Follow-up visits will take place on days 5, 14, 21 and 29. Some visits can be made by phone or video call.
Diana Florescu, MD, professor in the department of internal medicine at UNMC and infectious disease specialist at Nebraska Medicine, is leading the clinical trial at UNMC.
âFor many years, antivirals such as this drug have been effective in preventing disease after exposure to various pathogens and in reducing the risk of the infection spreading to close contacts,â said Florescu. “We hope that molnupiravir will reduce the transmission of SARS-CoV-2 between family members and prevent disease after exposure to SARS-CoV-2, including variants with advanced genetic mutations for which current vaccines may not provide protection. “
Approximately 1,300 participants will be recruited for the international study, which will take approximately one month from the time the participant provides documented informed consent, until final contact.
There is no cost for the trial drug or for the tests and medical examinations associated with the trial.
You may be eligible if you:
- Be at least 19 years old
- You have not received a COVID-19 vaccine
- I have never had COVID-19
- Living with someone who recently tested positive for COVID-19
If you would like to know more about the study, email [email protected] or call 402-559-7685 and reference the IRB study # 465-21-CB.